NCT02514629

Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

Randomized, Double-blind, Parallel, Placebo-controlled, Clinical Trial to Assess the Efficacy of Testosterone, Metformin, or Both, for the Treatment of Obesity-induced Male Hypogonadism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo

Conditions

• Hypogonadism
• Obesity

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Metformin
DRUG	Testosterone Undecanoate
DRUG	Metformin + Testosterone Undecanoate

Timeline

• Start date: 2013-07-04
• Primary completion: 2016-07-12
• Completion: 2016-07-12
• First posted: 2015-08-04
• Last updated: 2024-12-13

Locations

1 site across 1 country: Spain